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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05612035
Other study ID # 5475-013
Secondary ID MK-5475-0132022-
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 16, 2023
Est. completion date March 23, 2028

Study information

Verified date June 2024
Source Merck Sharp & Dohme LLC
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of once daily oral inhalation dose of MK-5475 380 µg in participants 40 to 85 years (inclusive) with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD). The primary hypothesis of the study is MK-5475, a soluble Guanylate Cyclase (sGC) stimulator is superior to placebo in increasing 6 Minute Walking Distance (6MWD) from baseline at Week 24.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 23, 2028
Est. primary completion date April 7, 2026
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: - Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension. - Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria. - Has a physician diagnosis of obstructive lung disease on pulmonary function testing (PFT) performed at screening. - Has a WHO Functional Class assessment of Class II to IV. - If on supplemental oxygen, the regimen must be stable. - Has stable and optimized chronic, baseline COPD-specific therapy. - If on PDE5 inhibitor, has stable concomitant use (initiated at least 3 months prior to randomization and no change in drug or dosage for at least 3 months prior to randomization) and changes to PDE5 inhibitor dosing is not anticipated during the 24 week Base Period. - If on antihypertensives and/or a diuretic regimen has stable concomitant use. - If on anticoagulants has stable concomitant use. - Is of any sex/gender from 40 to 85 years of age inclusive. - Female is not pregnant or breastfeeding, and is not of childbearing potential or uses acceptable contraceptive method or abstains from sexual intercourse, or has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention, or whose history and sexual activity has been reviewed by the investigator. Exclusion criteria: - Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH). - Has non-COPD related Group 3 PH. - Has evidence of untreated more than mild obstructive sleep apnea. - Has significant left heart disease. - Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period. - Has evidence of a resting oxygen saturation (SpO2) < 88%. - Has experienced a moderate or severe COPD exacerbation within 2 months before randomization. - Has experienced right heart failure within 2 months before randomization. - Has uncontrolled tachyarrhythmia. - Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization. - Has evidence of significant chronic renal insufficiency. - Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities. - Initiated a pulmonary rehabilitation program within 2 months before randomization. - Has impairments that limit the ability to perform 6MWT. - Has history of cancer. - Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence. - Has used PAH-specific therapies within 2 months of randomization.

Study Design


Intervention

Drug:
MK-5475
MK-5475 380 µg administered as dry powder inhalation once daily.
Placebo
Placebo administered as dry powder inhalation once daily.

Locations

Country Name City State
Argentina Fundación Respirar ( Site 0305) Buenos Aires
Argentina Hospital Privado Universitario de Córdoba-Clinical Cardiology Department ( Site 0302) Cordoba
Argentina Centro Medico Capital ( Site 0301) La PLata Buenos Aires
Argentina Instituto de Cardiologia de Tucuman-Area de Investigacion Clinica ( Site 0303) San Miguel de Tucumán Tucuman
Australia The Prince Charles Hospital ( Site 0904) Brisbane Queensland
Australia Mater Misericordiae Limited ( Site 0905) South Brisbane Queensland
Australia Westmead Hospital-Department of Respiratory and Sleep Medicine ( Site 0902) Westmead New South Wales
Austria Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1201) Graz Steiermark
Austria Medizinische Universitaet Innsbruck ( Site 1202) Innsbruck Tirol
Belgium Université Libre de Bruxelles - Hôpital Erasme ( Site 1302) Brussels Bruxelles-Capitale, Region De
Colombia Ciensalud Ips S A S ( Site 0508) Barranquilla Atlantico
Colombia Centro de Investigaciones Clinicas SAS ( Site 0505) Cali Valle Del Cauca
Colombia Fundación Valle del Lili ( Site 0509) Cali Valle Del Cauca
Colombia Clinica Cardio VID ( Site 0504) Medellín Antioquia
France Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1501) Le Kremlin-Bicêtre Paris
France C.H.U Hôpital Nord ( Site 1503) Marseille Bouches-du-Rhone
France Centre Hospitalier Universitaire de Poitiers ( Site 1505) Poitiers Vienne
Germany Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1601) Dresden Sachsen
Germany UKGM Gießen/Marburg ( Site 1604) Gießen Hessen
Germany Medizinische Hochschule Hannover ( Site 1602) Hannover Niedersachsen
Germany Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 1603) Heidelberg Baden-Wurttemberg
Germany Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1605) Lübeck Schleswig-Holstein
Israel Rambam Health Care Campus ( Site 1701) Haifa
Israel Rabin Medical Center ( Site 1702) Petah Tikva
Italy Ospedale San Gerardo-ASST Monza-Cardio Vasolare- Clinica pneumologica ( Site 1802) Monza Lombardia
Italy ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ( Site 1804) Palermo
Italy Cattinara Hospital ( Site 1801) Trieste Friuli-Venezia Giulia
Korea, Republic of Gachon University Gil Medical Center ( Site 1101) Namdong-gu Incheon
Korea, Republic of Asan Medical Center ( Site 1102) Seoul
Korea, Republic of Seoul National University Hospital ( Site 1103) Seoul
Mexico Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0701) Mexico
Peru Unidad de Investigacon de la Clinica Internacional ( Site 0804) Cercado De Lima Lima
Peru Clinica Ricardo Palma-Centro de Investigacion de Enfermedades Respiratorias Thorax ( Site 0806) San Isidro Lima
Peru Clínica Providencia ( Site 0803) San Miguel Lima
South Africa TREAD Research ( Site 2101) Cape Town Western Cape
South Africa Netcare St Augustine's Hospital ( Site 2105) Durban Kwazulu-Natal
South Africa Netcare Milpark Hospital ( Site 2103) Johannesburg Gauteng
Spain HOSPITAL CLÍNIC DE BARCELONA ( Site 2001) Barcelona Cataluna
Spain Hospital Universitari Vall d'Hebron ( Site 2002) Barcelona Cataluna
Spain Parc de Salut Mar - Hospital del Mar ( Site 2006) Barcelona
Spain Hospital Universitario Marqués de Valdecilla-Pneumology ( Site 2003) Santander Cantabria
Spain HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2005) Sevilla
Switzerland Cantonal Hospital St.Gallen ( Site 2203) Sankt Gallen
Switzerland UniversitätsSpital Zürich ( Site 2201) Zürich Zurich
Turkey Ankara Bilkent Sehir Hastanesi. ( Site 2307) Ankara
Turkey Hacettepe Universite Hastaneleri ( Site 2301) Ankara
Turkey Eskisehir Osmangazi University-Cardiology ( Site 2304) Eskisehir
Turkey Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi-Chest Disease ( Site 2302) Istanbul
United Kingdom Hammersmith Hospital-Department of Cardiology ( Site 2401) London London, City Of
United Kingdom Sheffield Teaching Hospitals NHS Foundation Trust-Clinical Research Facility ( Site 2405) Sheffield
United States University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular Aurora Colorado
United States University of Virginia Health System-Division of Pulmonary and Critical Care Medicine ( Site 0111) Charlottesville Virginia
United States UT Southwestern Medical Center ( Site 0114) Dallas Texas
United States Alexian Brothers Medical Center-Pulmonary ( Site 0109) Elk Grove Village Illinois
United States Corewell Health ( Site 0133) Grand Rapids Michigan
United States The University of Texas Health Science Center at Houston ( Site 0105) Houston Texas
United States University of Iowa ( Site 0103) Iowa City Iowa
United States University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102) Kansas City Kansas
United States Lexington VA Medical Center - Cooper Division ( Site 0137) Lexington Kentucky
United States Intermountain Medical Center-Division of Pulmonary & Critical Care Medicine ( Site 0140) Murray Utah
United States Creighton University Clinical Research Office ( Site 0123) Omaha Nebraska
United States Temple University Hospital ( Site 0104) Philadelphia Pennsylvania
United States Mayo Clinic in Rochester, Minnesota ( Site 0131) Rochester Minnesota
United States Clinovation Intl. Corp. ( Site 0108) Sebring Florida

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Colombia,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Mexico,  Peru,  South Africa,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24 6MWD is assessed using the 6-minute walk test (6MWT). Baseline and Week 24
Secondary Mean Change From Baseline in 6MWD at Week 12 6MWD is assessed using the 6-minute walk test (6MWT). Baseline and Week 12
Secondary Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12 NT-proBNP was measured at baseline and Week 12. Baseline and Week 12
Secondary Mean Change From Baseline in NT-ProBNP at Week 24 NT-proBNP was measured at baseline and Week 24 Baseline and Week 24
Secondary Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12 Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase. Baseline and Week 12
Secondary Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24 Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase. Baseline and Week 24
Secondary Percentage of Participants With One or More Adverse Events (AEs) An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Up to Week 104
Secondary Percentage of Participants who Discontinued Study Treatment due to an AE An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be presented. Up to Week 102
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